FDA Enforcement
Class II
Ongoing
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Recall: Z-2594-2021
·
Reported October 6, 2021
Enforcement
- Recall Number
- Z-2594-2021
- Event ID
- 88521
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 6, 2021
- Initiation Date
- August 2, 2021
- Classification Date
- September 29, 2021
- Address
- No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, N/A, China
Description
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Reason
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Code Info
Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002
Distribution
U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
Quantity
1 system